Legal provisions of COM(2000)438-1 - Hygiene of foodstuffs - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2000)438-1 - Hygiene of foodstuffs. |
|---|---|
| document | COM(2000)438  |
| date | April 29, 2004 |
Contents
- Article 1 - Scope
- Article 2 - Definitions
- Article 3 - General obligation
- Article 4 - General hygiene requirements and specific hygiene requirements
- Article 5 - Hazard analysis and critical control points system
- Article 6 - Specific Food Safety requirements
- Article 7 - National guides to good practice and guides to the application of HACCP
- Article 8 - Community guides
- Article 9 - Registration or approval of Food Businesses
- Article 10 - Withdrawal of products/traceability
- Article 11 - Official controls
- Article 12 - Imports / exports
- Article 13 - Amending of annexes and implementing measures
- Article 14 - References to international standards
- Article 15 - Standing Committee procedure
- Article 16 - Report to Council and Parliament
- Article 17 - Entry into force
Article 1 - Scope
It applies to food businesses and does not apply to the primary production of food for private domestic use or the domestic preparation of foodstuffs for private consumption.
Article 2 - Definitions
- food hygiene, hereinafter called hygiene means the measures and conditions necessary to control hazards and ensure fitness for human consumption of a foodstuff taking into account its intended use;
- food safety means the assurance that food will not cause adverse health effects to the final consumer when it is prepared and eaten taking into account its intended use;
- food business means any undertaking, whether for profit or not and whether public or private, carrying out any or all of the stages from and including primary production up to and including the offering for sale or supply of foodstuffs to the final consumer;
- food business operator means the person or persons responsible for ensuring that the requirements of this Regulation are met within the food business under his/their control;
- primary products means products of the soil, of stock farming, of hunting and fisheries;
- primary production means the production, rearing or growing of primary products up to and including harvesting, hunting, fishing, milking and all stages of animal production prior to slaughter;
- competent authority/ies means the central authority/ies of a Member State responsible for the purposes and controls set out in this Regulation or any other authority or body to which competence has been delegated by the central authority/ies;
- certification means the procedure by which the competent authorities provide written or equivalent assurance of conformity to requirements;
- equivalence means the capability of different systems to meet the same objectives;
- hazard means a biological, chemical or physical agent with the potential to compromise food safety;
- contamination means the presence of a substance not intentionally added to the food or present in the food environment, which may compromise the safety or fitness for human consumption of the food;
- marketing means holding, displaying and offering for sale, selling, delivering or any other form of placing on the market in the Community;
- retail trade means the handling and processing of food and its storage at the point of sale or delivery to the final consumer, and includes mass catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres, wholesale outlets selling wrapped and packaged foodstuffs;
- final consumer means the ultimate consumer of a foodstuff who shall not use the food as part of any food business operation or activity;
- wrapping means the protection of a product by the use of an initial wrapping or initial container in direct contact with the product concerned, and the initial wrapper or initial container itself;
- packaging means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself; if wrapping is strong enough to ensure effective protection, it can be considered to be packaging;
- 'products of animal origin' means foodstuffs obtained from animals, including honey;
- 'product of plant origin' means foodstuffs obtained from plants;
- unprocessed product means foodstuffs which have not undergone a treatment, including products which have been, for example, divided, parted, severed, boned, minced, skinned, ground, cut, cleaned, trimmed, husked or milled, chilled, frozen or deep-frozen;
- processed product means foodstuffs resulting from the application to unprocessed products of a treatment such as heating, smoking, curing, maturing, pickling, drying, marinating, extraction, extrusion etc. or a combination of these processes and/or products; substances necessary for their manufacture or for giving specific characteristics to the products may be added;
- hermetically sealed container means a container that is designed and intended to be secure against the entry of micro-organisms;
- where necessary, where appropriate, sufficient mean where revealed necessary, appropriate or sufficient after hazard analysis in the context of the HACCP system.
Article 3 - General obligation
Article 4 - General hygiene requirements and specific hygiene requirements
2. Food business operators, other than referred to in paragraph 1, shall comply with the general hygiene provisions in Annex II, any other specific provisions laid down in Regulation ... (laying down specific hygiene rules for food of animal origin) and in any other annexes which may be added in accordance with the procedure laid down in Article 15.
3. Exemptions from provisions of the Annexes referred to in paragraphs 1 and 2 may be granted by the Commission in accordance with the procedure laid down in Article 15, provided that such exemptions do not affect the achievement of the objectives of this Regulation.
4. Member States may adapt the requirements laid down in Annex II with a view to accommodate the needs of food businesses situated in regions suffering from special geographical constraints or affected by supply difficulties which are serving the local market, or with a view to take account of traditional methods of production. The objectives of food hygiene shall not be compromised.
Member States having recourse to this possibility shall inform the Commission and the other Member States thereof. Member States shall have one month from the receipt of the notification to send written comments to the Commission. Where written comments are made, the Commission shall take a decision in accordance with the procedure referred to in Article 15(2).
Article 5 - Hazard analysis and critical control points system
a) identify any hazards that must be prevented, eliminated or reduced to acceptable levels,
b) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it acceptable levels,
c) establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards,
d) establish and implement effective monitoring procedures at critical control points,
e) establish corrective actions when monitoring indicates that a critical control point is not under control.
2. Food business operators shall establish procedures to verify whether the measures outlined in paragraph 1 are working effectively. Verification procedures shall be carried out regularly and whenever the food business operation changes in a manner that could adversely affect food safety.
3. Food business operators shall establish documents and records commensurate to the nature and size of the food business to demonstrate the effective application of the measures outlined in paragraphs 1 and 2, and to facilitate official controls. Such documents shall be kept by the food business operator for at least the time of the shelf life of the product.
4. As part of the system referred to in paragraphs 1, 2 and 3, food business operators may use guides to good practice in conjunction with guides on the application of HACCP, as developed in accordance with Articles 7 and 8. Such guides must be appropriate for the operations and foods to which they are applied by the food business operator.
5. In accordance with the procedure referred to in Article 15, the Commission may adopt measures in order to facilitate the implementation of this Article, in particular in small businesses.
Article 6 - Specific Food Safety requirements
1. Microbiological criteria and temperature criteria for foodstuffs may be adopted and/or amended,
2. Targets and/or performance standards in order to facilitate the implementation of this Regulation may be set.
Article 7 - National guides to good practice and guides to the application of HACCP
2. Where the guides to good practice referred to in paragraph 1 are developed, they shall be developed as follows:
- by food business sectors and representatives of other interested parties, such as appropriate authorities and consumer groups,
- in consultation with interests substantially affected, including competent authorities,
- where appropriate, having regard to the Recommended International Codes of Practice of the Codex Alimentarius.
National guides may be developed under the aegis of a national standards institute referred to in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations as amended by Directive 98/48/EC .
OJ L 204, 21.7.1998, p. 37.
OJ L 217, 5.8.1998, p. 18.
3. Member States shall assess national guides to ensure:
- that the contents of such guides are practicable for the sectors to which they refer,
- have been developed in association with representatives of the sector concerned and other interested parties, such as appropriate competent authorities and consumer groups,
- have been developed having regard to the Recommended International Code of Practice, General Principles of Food Hygiene, of the Codex Alimentarius,
- that all interested parties substantially affected have been consulted and the relevant comments taken into account,
- their suitability as guides to compliance with the provisions of Articles 3, 4, and 5 in the sectors and/or for the foodstuffs covered.
4. Twelve months following the coming into force of this Regulation, and thereafter annually, the Member States shall forward to the Commission a report concerning the steps taken to develop national guides specified in paragraph 1.
5. Member States shall forward to the Commission those national guides which they have determined to comply with paragraphs 3 of this Article. The Commission shall keep a register of such guides and make this available to the Member States.
Article 8 - Community guides
2. Where Community guides are prepared, steps shall be taken to ensure that they are developed with representatives of the sector concerned and other interested parties, such as appropriate competent authorities and consumer groups, taking into account the Recommended International Code of Practice, General Principles of Food Hygiene, of the Codex Alimentarius and any national guides developed in accordance with Article 7.
3. The relevant Committee or Committees referred to in Article 15 shall be responsible for assessing Community guides. Measures shall be taken by such Committee or Committees to ensure that:
- the contents of such guides are practicable for the sectors to which they refer throughout the Community,
- all interests substantially affected by such guides have been consulted, and the relevant comments taken into account,
- where they exist, national guides forwarded to the Commission under Article 7(5) have been taken into account,
- their suitability as guides to compliance with the provisions of Articles 3, 4, and 5 in the sectors and/or for the foodstuffs covered.
4. Where national guides have been produced in accordance with Article 7 and subsequently Community guides are produced in accordance with this Article, food business operators may refer to either.
5. The titles and references of Community guides prepared in accordance with the procedure in paragraphs 1 to 3 shall be published in the C series of the Official Journal of the European Communities. Member States shall ensure that such published guides are drawn to the attention of the relevant food business sectors and the appropriate authorities in their territories.
Article 9 - Registration or approval of Food Businesses
2. Food business operators except those operating at retail level shall ensure that foodstuffs produced by them are identified with their registration number.
3. Where the Competent Authority/ies considers it necessary for the purposes of assuring that the requirements of this Regulation are met, or where required by more specific Community rules, food businesses must be approved and shall not operate without such approval. The Competent Authority shall only approve those establishments where, after a visit by officials of the competent authority/ies it has been ascertained that all the requirements of this regulation are met.
Article 10 - Withdrawal of products/traceability
2. Food business operators shall keep adequate records which enable them to identify the supplier of ingredients and foods used in their operation and where appropriate the provenance of the animals used for food production.
3. Where necessary to ensure appropriate traceability of food or food ingredients, the Commission shall lay down detailed rules in accordance with the procedure provided for in Article 15.
Article 11 - Official controls
- give access to all buildings, premises, installations or other infrastructures,
- make available any documentation and record required under the present Regulation or considered necessary by the competent authority for judging the situation.
Article 12 - Imports / exports
2. Foodstuffs for exportation out of the Community shall comply with the provisions of Articles 3, 4 5, 9 and any provisions laid down under Article 6, except where the importing country specifies otherwise.
Article 13 - Amending of annexes and implementing measures
2. Implementing measures in relation to Articles , 4, 5, 9, 10 and 12 may be adopted in accordance with the procedure laid down in Article 15.
Article 14 - References to international standards
Article 15 - Standing Committee procedure
OJ L 255, 18.10.1968, p. 23.
OJ L 291, 19.11.1969, p. 9.
2. Where reference is made to this paragraph, the Regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof.
3. The period provided for in Article 5(6) of decision 1999/468/EC shall be 3 months.
Article 16 - Report to Council and Parliament
2. In order to allow the Commission to establish the report referred to in paragraph 1, Member States shall submit all necessary information to the Commission 12 months before the period referred to in paragraph 1.
Article 17 - Entry into force
It shall apply from 1 January 2004.
This Regulation shall be binding in its entirety and directly applicable in all Member States.